MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, lot# n275013009, implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: catheter. Product id: 8709sc, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient who was receiving baclofen (500 mcg/day, 1250 mcg/ml), morphine (1500 mcg/day, 3750 mcg/ml) and bupivacaine (10000 mcg/day, 25000 mcg/ml) via intrathecal drug delivery pump for an unknown indication for use. It was reported that the patient presented to the emergency room on (b)(6) 2018 exhibiting signs of baclofen withdrawal (return of spasticity, difficulty breathing and swallowing). The symptoms progressed until the patient lost consciousness. The patient had gone in for refill on (b)(6) 2018. Her managing physician turned off the pump and sent her home with oral medications. There were no known diagnostics or troubleshooting performed. The patient's pump showed it was at end of service (eos) "in 2 months. " a decision was made to replace the pump and reinitiate baclofen therapy. During the replacement procedure, the catheter could not be aspirated, so a new catheter was also placed. It was unknown whether the issue was resolved at the time of this report. The explanted pump would not be returned; it was discarded by the customer. The tip of the catheter remained in the patient. It did not come out easily and was clamped off. The explanted portion of the catheter was discarded by the customer. The patient status at the time of this report was "alive - with injury. " the patient returned to the intensive care unit and remained intubated. No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional via manufacturer representative. It was reported that the patient was doing well and continued to improve. X-ray imaging of the catheter in-vivo was performed as a diagnostic. No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7432825
• MDR Text Key: 105562684
• Report Number: 3004209178-2018-08103
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/04/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/16/2018 Patient Sequence Number: 1